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Description of key information

Not irritant to skin and eye of rabbits.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

No data on target substance was available, thus a read across approach was followed. In particular, available data on Similar Substance 01, i.e. one of the major components of target UVCB substance, was used. Such component shows slight differences with respect to other minor components of the UVCB substance. Further details are available in section 13.

Skin and eye irritation potential of test susbtance was assessed as described by AFDO (1959).

In the skin irritation study, 6 rabbits were used and test substance was applied on both intact and scarified skin for 24 h. After removal, skin reactions were scored at 24 h and at 72 h. No reactions were noted.

In the eye irritation study, 6 rabbits were used and test substance was applied to one eye for 30 seconds, then treated eye was rinsed. No signs of irritation were noted on cornea and iris. Slight irritation on conjunctiva was reported, but information reported in the study report did not allow to distinguish among redness, chemosis and discharge. However, such signs were fully recovered within 7 days in all rabbits.

Justification for classification or non-classification

Skin Irritation

According to the CLP Regulation (EC 1272/2008), skin corrosion means the production of irreversible damage to the skin, and skin irritation means the production of reversible damage to the skin following the application of a test substance for up to 4 hours.

A substance has to be classified as category 1 (corrosive) if it produces destruction of skin tissue, namely, visible necrosis through the epidermis and into the dermis, in at least 1 tested animal after exposure up to a 4 hour duration.

 

A substance has to be classified as category 2 (irritant) if shows:

(1) mean value of ≥ 2,3 - ≤ 4,0 for erythema/ eschar or for oedema in at least 2 of 3 tested animals from gradings at 24, 48 and 72 hours after patch removal or, if reactions are delayed, from grades on 3 consecutive days after the onset of skin reactions; or

(2) inflammation that persists to the end of the observation period normally 14 days in at least 2 animals, particularly taking into account alopecia (limited area), hyperkeratosis, hyperplasia, and scaling; or

(3) in some cases where there is pronounced variability of response among animals, with very definite positive effects related to chemical exposure in a single animal but less than the criteria above.

In case 6 rabbits are used, a response above the threshold of 2.3 in 4 of 6 rabbits implies a classification in category 2.

As no irritation was seen, no classification applied within the CLP Regulation (EC 1272/2008).

 

Eye Irritation

According to the CLP Regulation (EC 1272/2008), serious eye damage means the production of tissue damage in the eye, or serious physical decay of vision, following application of a test substance to the anterior surface of the eye, which is not fully reversible within 21 days of application .

Eye irritation means the production of changes in the eye following the application of test substance to the anterior surface of the eye, which are fully reversible within 21 days of application.

 

A substance has to be classified as category 1 (irreversible effects on the eye), If, when applied to the eye of an animal, a substance produces:

- at least in one animal effects on the cornea, iris or conjunctiva that are not expected to reverse or have not fully reversed within an observation period of normally 21 days; and/ or

- at least in 2 of 3 tested animals, a positive response of:

- corneal opacity ≥ 3 and/or

- iritis > 1,5 calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material.

 

A substance has to be classified as category 2 (irritating to eye) if, when applied to the eye of an animal, a substance produces:

at least in 2 of 3 tested animals, a positive response of:

- corneal opacity ≥ 1 and/or

- iritis ≥ 1, and/or

- conjunctival redness ≥ 2 and/or

- conjunctival oedema (chemosis) ≥ 2

calculated as the mean scores following grading at 24, 48 and 72 hours after installation of test material, and which fully reverses within an observation period of 21 days.

In case 6 rabbits are used, a response above the threshold in 4 of 6 rabbits implies a classification in category 2.

As irritation effects, only on conjunctiva, were slight and recovered within 48 hours in 5/6 rabbits and within 7 days in 1/6 rabbits, no classification applied within the CLP Regulation (EC 1272/2008).

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